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ALL-IN-ONE relief
Here with you with results in all key clinical manifestations of psoriatic arthritis (PsA) for up to 2 years1-5
Please see clinical trial primary end points, key data, and study designs
In FUTURE 5, ACR50, dactylitis, enthesitis, mNAPSI, and PASI 90 were prespecified exploratory end points at 2 years, and PASI 100 was a post hoc analysis based on PASI 90. In MAXIMISE, ASAS20 at 1 year was a prespecified exploratory end point. No clinical or statistical conclusions can be drawn.1-3,5,6
Data from the MAXIMISE trial, whose study design, patient population, and dosing regimen are consistent with those of FUTURE 2. In FUTURE 2, 20% of patients had spondylitis with peripheral arthritis. MAXIMISE primary end point: 63% experienced relief on COSENTYX 300 mg at Week 12 vs 31% with placebo, as measured by ASAS20 (P<0.0001) (n=164) (MI).2
Nail data in PsA from FUTURE 5 at Week 16 (mixed population) were consistent with those in the dedicated nail PsO study, TRANSFIGURE. Improvement from baseline NAPSI at Week 16 (primary end point) (repeated measures analysis) was 46.1% for COSENTYX 300 mg (n=63) and 11.7% for placebo (n=56) (P<0.0001).7
At baseline in FUTURE 5 (mixed population), mNAPSI scores were 18.0 and 17.8 in the 300-mg and 150-mg arms, respectively. At Week 16, mNAPSI scores were 8.8 and 8.4 in the 300-mg and 150-mg arms, respectively.6
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Here for your community
*FDA approved for active PsA and AS in 2016.
Hear what matters to patients
Here with you because relief can’t come soon enough
In FUTURE 5
Fast relief of joint symptoms as early as Week 21
ACR20 response at Week 2 in a mixed population1
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31% for COSENTYX 300 mg (n=222)
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26% for COSENTYX 150 mg (n=220)
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15% for placebo (n=332)
In FUTURE 5, ACR20 was a prespecified exploratory end point at Week 2. No clinical or statistical conclusions can be drawn.1
Relief for your biologic-naive patients with PsA
In FUTURE 5, ACR50 was a prespecified exploratory end point at Week 16 in a subgroup of biologic-naive patients. No clinical or statistical conclusions can be drawn.1
Here with you for the long term
In FUTURE 2, as observed in biologic-naive patients with psoriatic arthritis (PsA)
Lasting joint results at 5 years1
In FUTURE 2, ACR20, ACR50, and ACR70 were prespecified exploratory end points from baseline through 5 years in a subgroup of biologic-naive patients. No clinical or statistical conclusions can be drawn.2
Hear what matters to patients
A patient’s experience:
“When the disease is managed well, I can do most things I need to do. I can’t think of anything it has prevented me from doing.”
Meet Mike
Mike, an actual patient with PsA on COSENTYX, was compensated for his time. Individual results may vary.
As with other uncontrolled studies, this phase of the study has limitations (eg, no placebo comparisons, and patients responding better are more likely to stay in the study over time).
At baseline, n=67 and n=63 were biologic-naive in the 300-mg and 150-mg arms, respectively.2
In the mixed population: 74% of patients in the 300-mg arm and the 150-mg arm achieved an ACR20 response; 48% of patients in the 300-mg arm and 42% in the 150-mg arm achieved an ACR50 response; 28% of patients in the 300-mg arm and 29% in the 150-mg arm achieved an ACR70 response.1
*73% and 76% completed the extension treatment period in the 300-mg arm and 150-mg arm, respectively.1
Tried and tested specifically for axial symptoms of PsA
In MAXIMISE, as observed in biologic-naive patients with PsA
Demonstrated improvement in axial symptoms1,2
ASAS20 responses at Week 12 (MI) were1:
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63%, 66%, and 31% for COSENTYX 300 mg (primary end point; n=164), COSENTYX 150 mg (key secondary end point; n=157), and placebo (n=164), respectively (P<0.0001)
In MAXIMISE, ASAS20 and ASAS40 were prespecified exploratory end points at 1 year. No clinical or statistical conclusions can be drawn.2
ASAS components are relevant to your patients with PsA and include4:
Data from the MAXIMISE trial, whose study design, patient population, and dosing regimen were consistent with those of FUTURE 2. In FUTURE 2, 20% of patients had spondylitis with peripheral arthritis.
*85% and 90% of patients completed the trial in the 300-mg and 150-mg arms, respectively.2
Here with you to reduce the burden of enthesitis
In FUTURE 5, as observed in biologic-naive patients
Complete resolution of enthesitis1
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Complete resolution of enthesitis at Week 16 in a mixed population (prespecified secondary end point) using NRI analysis: 56% for COSENTYX 300 mg (n=140) and 55% for COSENTYX 150 mg (n=141) vs 35% for placebo (n=192)2
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82% of patients achieved complete resolution of enthesitis at 2 years in the 150-mg arm1
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Among patients with enthesitis, 40% of biologic-naive patients in the COSENTYX 150-mg arm were up-titrated to 300 mg starting at Week 52, at the investigator’s discretion1
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In FUTURE 5, complete resolution of enthesitis was a prespecified exploratory end point at 2 years in a subgroup of biologic-naive patients with LEI >0 at baseline. No clinical or statistical conclusions can be drawn.3
As with other uncontrolled studies, this phase of the FUTURE 5 study has limitations (eg, no placebo comparisons, and patients responding better are more likely to stay in the study over time).
At baseline, 97 patients and 93 patients in FUTURE 5 had enthesitis in the 300-mg and 150-mg arms, respectively (biologic-naive).3
*Patients with no enthesitis are defined as having an LEI score of 0 among patients with a score of 1 or more at baseline.3
†91% of patients completed the study in both the 300-mg and 150-mg arms.1
Here with you to help your patients with “sausage digits”
In FUTURE 5, as observed in biologic-naive patients
Complete resolution of dactylitis1
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Complete resolution of dactylitis at Week 16 in a mixed population (prespecified secondary end point) using NRI analysis: 66% for COSENTYX 300 mg (n=82) and 57% for COSENTYX 150 mg (n=80) vs 32% for placebo (n=124)2
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86% of patients achieved complete resolution of dactylitis at 2 years in the 150-mg arm1
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Among patients with dactylitis, 56% of biologic-naive patients in the COSENTYX 150-mg arm were up-titrated to 300 mg starting at Week 52, at the investigator’s discretion1
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In FUTURE 5, complete resolution of dactylitis was a prespecified exploratory end point at 2 years in a subgroup of biologic-naive patients with LDI >0 at baseline. No clinical or statistical conclusions can be drawn.2
As with other uncontrolled studies, this phase of the FUTURE 5 study has limitations (eg, no placebo comparisons, and patients responding better are more likely to stay in the study over time).
At baseline, 55 patients and 52 patients had dactylitis in the 300-mg and 150-mg arms, respectively (biologic-naive).2
*Patients with no dactylitis are defined as having a LDI score of 0 among patients with a score of 1 or more at baseline.2
†87% and 84% of patients completed the study in the 300-mg and 150-mg arms, respectively.1
Here with you to help clear their skin
Real treatment success with COSENTYX
Skin clearance through 2 years
Actual patient photos representative of the average response taken by investigators during PsO clinical trials. Individual results may vary.
In FUTURE 5, as observed in biologic-naive patients
Your patients with PsA can achieve clearer skin1
In FUTURE 5, PASI 100 is a post hoc analysis in a subgroup of biologic-naive patients with PsA and PsO based on PASI 75 and PASI 90 as prespecified exploratory end points at 2 years. No clinical or statistical conclusions can be drawn.2
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66% PASI 90 response, 150 mg (n=84)3
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38% of patients with PsA and PsO in the COSENTYX 150-mg arm were up-titrated to 300 mg starting at Week 52, at the investigator's discretion1
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In FUTURE 5, PASI 90 was a prespecified exploratory end point at 2 years. Results were as observed in a subgroup of biologic-naive patients with PsA and plaque psoriasis. No clinical or statistical conclusions can be drawn.
Hear what matters to patients
A patient’s experience:
COSENTYX for PsA with psoriasis
Meet Mike
Mike, an actual patient with PsA on COSENTYX, was compensated for his time. Individual results may vary.
Transcript
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*91% and 90% of patients completed the two-year clinical trial in the 300-mg and 150-mg arms, respectively.1
Here with you for relief of stubborn nail symptoms
Real treatment success with COSENTYX
Patient photos taken from a dedicated nail PsO trial
Baseline
Week 16
Week 32
Week 80
Actual patient photos representative of the average response taken by investigators during PsO clinical trials. Individual results may vary.
Look between the cuticle and the new nail to see treatment success. It can take on average about 24 weeks to 1 year for the nail to grow out.1
In FUTURE 5, as observed in biologic-naive patients
Nail clearance through 2 years2
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46% of patients with nail psoriasis were up-titrated from 150 mg to 300 mg starting at Week 12, at the investigator’s discretion2
In FUTURE 5, mNAPSI, a measure used to assess psoriatic nail involvement, was a prespecified exploratory end point in a subgroup of biologic-naive patients with PsA and nail psoriasis. No clinical or statistical conclusions can be drawn.3
Nail data in PsA were consistent with those in the dedicated nail PsO study, TRANSFIGURE. Improvement from baseline NAPSI at Week 16 (primary end point) (repeated measures analysis) was 46.1% for COSENTYX 300 mg (n=63) and 11.7% for placebo (n=56) (P<0.0001).4
At baseline, 66% and 61% of biologic-naive patients had nail psoriasis in the 300-mg and 150-mg arms, respectively. Mean baseline and 2-year mNAPSI values were 19.2 and 3.1, and 19.7 and 2.2, in the 300-mg and 150-mg arms, respectively.2,3
*79% and 83% of patients completed the trial in the 300-mg and 150-mg arms, respectively.2
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INDICATIONS
COSENTYX is indicated for the treatment of moderate to severe plaque psoriasis in patients 6 years and older who are candidates for systemic therapy or phototherapy.
COSENTYX is indicated for the treatment of active psoriatic arthritis (PsA) in patients 2 years of age and older.
COSENTYX is indicated for the treatment of adult patients with active ankylosing spondylitis (AS).
COSENTYX is indicated for the treatment of adult patients with active non-radiographic axial spondyloarthritis (nr-axSpA) with objective signs of inflammation.
COSENTYX is indicated for the treatment of active enthesitis-related arthritis (ERA) in patients 4 years of age and older.
Click or scroll down to see full Indications and Important Safety Information
IMPORTANT
SAFETY INFORMATION
CONTRAINDICATIONS
COSENTYX® (secukinumab) is contraindicated in patients with a previous serious hypersensitivity reaction to secukinumab or to any of the excipients in COSENTYX. Cases of anaphylaxis have been reported during treatment with COSENTYX.
WARNINGS AND PRECAUTIONS
Infections
COSENTYX may increase the risk of infections. In clinical trials, a higher rate of infections was observed in COSENTYX treated subjects compared to placebo-treated subjects. In placebo-controlled clinical trials in subjects with moderate to severe plaque psoriasis, higher rates of common infections, such as nasopharyngitis (11.4% versus 8.6%), upper respiratory tract infection (2.5% versus 0.7%) and mucocutaneous infections with candida (1.2% versus 0.3%) were observed with COSENTYX compared with placebo. A similar increase in risk of infection was seen in placebo-controlled trials in subjects with psoriatic arthritis, ankylosing spondylitis and non-radiographic axial spondyloarthritis. The incidence of some types of infections appeared to be dose-dependent in clinical studies. In the postmarketing setting, serious and some fatal infections have been reported in patients receiving COSENTYX.
Click or scroll down to see full Indications and Important Safety InformationExercise caution when considering the use of COSENTYX in patients with a chronic infection or a history of recurrent infection.
Instruct patients to seek medical advice if signs or symptoms suggestive of an infection occur. If a patient develops a serious infection, monitor the patient closely and discontinue COSENTYX until the infection resolves.
Pre-treatment Evaluation for Tuberculosis
Evaluate patients for tuberculosis (TB) infection prior to initiating treatment with COSENTYX. Avoid administration of COSENTYX to patients with active TB infection. Initiate treatment of latent TB prior to administering COSENTYX. Consider anti-TB therapy prior to initiation of COSENTYX in patients with a past history of latent or active TB in whom an adequate course of treatment cannot be confirmed. Monitor patients closely for signs and symptoms of active TB during and after treatment.
Inflammatory Bowel Disease
Caution should be used when prescribing COSENTYX to patients with inflammatory bowel disease. Exacerbations, in some cases serious, occurred in COSENTYX treated subjects during clinical trials in plaque psoriasis, psoriatic arthritis, ankylosing spondylitis and non-radiographic axial spondyloarthritis. In addition, new onset inflammatory bowel disease cases occurred in clinical trials with COSENTYX. In an exploratory trial in 59 subjects with active Crohn’s disease, there were trends toward greater disease activity and increased adverse events in the secukinumab group as compared to the placebo group. Patients who are treated with COSENTYX should be monitored for signs and symptoms of inflammatory bowel disease.
Hypersensitivity Reactions
Anaphylaxis and cases of urticaria occurred in COSENTYX treated subjects in clinical trials. If an anaphylactic or other serious allergic reaction occurs, administration of COSENTYX should be discontinued immediately and appropriate therapy initiated.
The removable caps of the COSENTYX Sensoready® pen and the COSENTYX 1 mL and 0.5 mL prefilled syringes contain natural rubber latex, which may cause an allergic reaction in latex-sensitive individuals. The safe use of the COSENTYX Sensoready pen or prefilled syringe in latex-sensitive individuals has not been studied.
Immunizations
Prior to initiating therapy with COSENTYX, consider completion of all age appropriate immunizations according to current immunization guidelines. COSENTYX may alter a patient’s immune response to live vaccines. Avoid use of live vaccines in patients treated with COSENTYX.
MOST COMMON ADVERSE REACTIONS
Most common adverse reactions (>1%) are nasopharyngitis, diarrhea, and upper respiratory tract infection.
Please see full Prescribing Information, including Medication Guide.
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IMPORTANT
SAFETY INFORMATION
CONTRAINDICATIONS
COSENTYX® (secukinumab) is contraindicated in patients with a previous serious hypersensitivity reaction to secukinumab or to any of the excipients in COSENTYX. Cases of anaphylaxis have been reported during treatment with COSENTYX.
Click or scroll down to see full Indications and Important Safety InformationWARNINGS AND PRECAUTIONS
Infections
COSENTYX may increase the risk of infections. In clinical trials, a higher rate of infections was observed in COSENTYX treated subjects compared to placebo-treated subjects. In placebo-controlled clinical trials in subjects with moderate to severe plaque psoriasis, higher rates of common infections, such as nasopharyngitis (11.4% versus 8.6%), upper respiratory tract infection (2.5% versus 0.7%) and mucocutaneous infections with candida (1.2% versus 0.3%) were observed with COSENTYX compared with placebo. A similar increase in risk of infection was seen in placebo-controlled trials in subjects with psoriatic arthritis, ankylosing spondylitis and non-radiographic axial spondyloarthritis. The incidence of some types of infections appeared to be dose-dependent in clinical studies. In the postmarketing setting, serious and some fatal infections have been reported in patients receiving COSENTYX.
Exercise caution when considering the use of COSENTYX in patients with a chronic infection or a history of recurrent infection.
Instruct patients to seek medical advice if signs or symptoms suggestive of an infection occur. If a patient develops a serious infection, monitor the patient closely and discontinue COSENTYX until the infection resolves.
Pre-treatment Evaluation for Tuberculosis
Evaluate patients for tuberculosis (TB) infection prior to initiating treatment with COSENTYX. Avoid administration of COSENTYX to patients with active TB infection. Initiate treatment of latent TB prior to administering COSENTYX. Consider anti-TB therapy prior to initiation of COSENTYX in patients with a past history of latent or active TB in whom an adequate course of treatment cannot be confirmed. Monitor patients closely for signs and symptoms of active TB during and after treatment.
Inflammatory Bowel Disease
Caution should be used when prescribing COSENTYX to patients with inflammatory bowel disease. Exacerbations, in some cases serious, occurred in COSENTYX treated subjects during clinical trials in plaque psoriasis, psoriatic arthritis, ankylosing spondylitis and non-radiographic axial spondyloarthritis. In addition, new onset inflammatory bowel disease cases occurred in clinical trials with COSENTYX. In an exploratory trial in 59 subjects with active Crohn’s disease, there were trends toward greater disease activity and increased adverse events in the secukinumab group as compared to the placebo group. Patients who are treated with COSENTYX should be monitored for signs and symptoms of inflammatory bowel disease.
Hypersensitivity Reactions
Anaphylaxis and cases of urticaria occurred in COSENTYX treated subjects in clinical trials. If an anaphylactic or other serious allergic reaction occurs, administration of COSENTYX should be discontinued immediately and appropriate therapy initiated.
The removable caps of the COSENTYX Sensoready® pen and the COSENTYX 1 mL and 0.5 mL prefilled syringes contain natural rubber latex, which may cause an allergic reaction in latex-sensitive individuals. The safe use of the COSENTYX Sensoready pen or prefilled syringe in latex-sensitive individuals has not been studied.
Immunizations
Prior to initiating therapy with COSENTYX, consider completion of all age appropriate immunizations according to current immunization guidelines. COSENTYX may alter a patient’s immune response to live vaccines. Avoid use of live vaccines in patients treated with COSENTYX.
MOST COMMON ADVERSE REACTIONS
Most common adverse reactions (>1%) are nasopharyngitis, diarrhea, and upper respiratory tract infection.
INDICATIONS
COSENTYX is indicated for the treatment of moderate to severe plaque psoriasis in patients 6 years and older who are candidates for systemic therapy or phototherapy.
COSENTYX is indicated for the treatment of active psoriatic arthritis (PsA) in patients 2 years of age and older.
COSENTYX is indicated for the treatment of adult patients with active ankylosing spondylitis (AS).
COSENTYX is indicated for the treatment of adult patients with active non-radiographic axial spondyloarthritis (nr-axSpA) with objective signs of inflammation.
COSENTYX is indicated for the treatment of active enthesitis-related arthritis (ERA) in patients 4 years of age and older.
Please see full Prescribing Information, including Medication Guide.
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